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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00018967




Registration number
NCT00018967
Ethics application status
Date submitted
11/07/2001
Date registered
27/01/2003
Date last updated
30/04/2015

Titles & IDs
Public title
Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate
Scientific title
A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose
Secondary ID [1] 0 0
NCI-92-C-0137N
Secondary ID [2] 0 0
CDR0000077521
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurotoxicity 0 0
Unspecified Adult Solid Tumor, Protocol Specific 0 0
Unspecified Childhood Solid Tumor, Protocol Specific 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Injuries and Accidents 0 0 0 0
Poisoning

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Patients who received an intrathecal overdose of methotrexate of 100 mg or more

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No prior anaphylactic reaction to carboxypeptidase-G2 administration

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* Concurrent therapy allowed
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Other
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/1993
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Delaware
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
Country [10] 0 0
United States of America
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Indiana
Country [11] 0 0
United States of America
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Iowa
Country [12] 0 0
United States of America
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Kansas
Country [13] 0 0
United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maine
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United States of America
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Maryland
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Massachusetts
Country [18] 0 0
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Michigan
Country [19] 0 0
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Minnesota
Country [20] 0 0
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Mississippi
Country [21] 0 0
United States of America
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Missouri
Country [22] 0 0
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Nebraska
Country [23] 0 0
United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
North Dakota
Country [28] 0 0
United States of America
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Ohio
Country [29] 0 0
United States of America
State/province [29] 0 0
Oklahoma
Country [30] 0 0
United States of America
State/province [30] 0 0
Oregon
Country [31] 0 0
United States of America
State/province [31] 0 0
Pennsylvania
Country [32] 0 0
United States of America
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South Carolina
Country [33] 0 0
United States of America
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Tennessee
Country [34] 0 0
United States of America
State/province [34] 0 0
Texas
Country [35] 0 0
United States of America
State/province [35] 0 0
Utah
Country [36] 0 0
United States of America
State/province [36] 0 0
Vermont
Country [37] 0 0
United States of America
State/province [37] 0 0
Virginia
Country [38] 0 0
United States of America
State/province [38] 0 0
West Virginia
Country [39] 0 0
United States of America
State/province [39] 0 0
Wisconsin
Country [40] 0 0
Canada
State/province [40] 0 0
Alberta
Country [41] 0 0
Canada
State/province [41] 0 0
British Columbia
Country [42] 0 0
Canada
State/province [42] 0 0
Manitoba
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
Canada
State/province [45] 0 0
Saskatchewan
Country [46] 0 0
Switzerland
State/province [46] 0 0
Geneva

Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Children's Oncology Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from the toxic effects of chemotherapy.

PURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system toxic effects in patients given an accidental overdose of intrathecal methotrexate.
Trial website
https://clinicaltrials.gov/study/NCT00018967
Trial related presentations / publications
Widemann BC, Balis FM, Shalabi A, Boron M, O'Brien M, Cole DE, Jayaprakash N, Ivy P, Castle V, Muraszko K, Moertel CL, Trueworthy R, Hermann RC, Moussa A, Hinton S, Reaman G, Poplack D, Adamson PC. Treatment of accidental intrathecal methotrexate overdose with intrathecal carboxypeptidase G2. J Natl Cancer Inst. 2004 Oct 20;96(20):1557-9. doi: 10.1093/jnci/djh270.
Widemann BC, Balis FM, Shalabi A, et al.: Carboxypeptidase-G2 (CPDG2) treatment of accidental intrathecal (IT) methotrexate (MTX) overdose. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-490, 2002.
Public notes

Contacts
Principal investigator
Name 0 0
Brigitte C. Widemann, MD
Address 0 0
National Cancer Institute (NCI)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00018967